Events

Occlutech® Occluder Set Inventory 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Occlutech GmbH 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2017-01-23
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • 데이터 추가 비고
  • 원인
    A customer inadvertently used an expired occlutech flex ll pusher cable and noticed doing so shortly after the implantation procedure. there was no impact on the patient, the procedure, or the product performance. occlutech occluders and compatible pusher cables are packaged together into an occlutech product set which also contains the instructions for use and the patient information card. the outer label on the occlutech product set clearly shows the expiration dates of both the occluder and the pusher cable. as these dates can differ from each other it is important to check both dates to not miss the shortest expiration date. .

Device

Occlutech® Occluder Set Inventory
  • 모델명 / 제조번호(시리얼번호)
    All Lots/All Serial Numbers/All Sizes Occluders: Figulla Flex l ASD, Figulla Flex ll ASD, Figulla Flex l PFO, Figulla Flex ll PFO, Figulla Flexl UNI, Figulla Flex || UNI, Occlutech PDA Occluder, Occlutech PLD Occluder, Occlutech mVSD Occluder, Occlutech FASD Occluder All Lots/All Serial Numbers/All Sizes
  • Manufacturer
    Occlutech GmbH

Manufacturer

Occlutech GmbH